Once-daily versus twice-daily ramipril for kidney health in CKD patients with reduced ejection fraction heart failure
Official title: Comparative Effects of Single Versus Twice-Daily Ramipril Dosing on Renal Function in Patients With Chronic Kidney Disease and Heart Failure With Reduced Ejection Fraction: Evaluation of Plasma Renin Activity, Malondialdehyde, Interleukin-6, Albuminuria, and Cystatin C
Run by Universitas Sebelas Maret · NCT07259512 · Data updated 2026-11-12
This trial tests whether taking ramipril once a day or split into twice-daily doses better protects kidney function in adults who have chronic kidney disease and heart failure with reduced ejection fraction.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Universitas Sebelas Maret Academic / other |
| Locations | 1 site (Kartasura, Central Java) |
| Status | Recruiting |
| Started | June 30, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | January 31, 2026 |
| Registry record updated | December 10, 2025 |
| Trial ID | NCT07259512 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with chronic kidney disease stage 3–5 (not on dialysis) and heart failure with reduced ejection fraction (EF < 40%) who can stop ARBs/sacubitril-valsartan and have no ACE inhibitor contraindications are ideal candidates.
✕Probably not a fit
Patients on hemodialysis, those with prior ACE inhibitor intolerance or angioedema, pregnant people, or those with refractory hyperkalemia or symptomatic hypotension are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind, parallel-assignment trial compares ramipril 10 mg once daily with ramipril 5 mg twice daily in adults with CKD stage 3–5 (not on dialysis) and heart failure with reduced ejection fraction (EF < 40%). Participants receive assigned dosing for 30 days while researchers measure plasma renin activity, malondialdehyde, interleukin-6, albuminuria, and cystatin C to track renal and inflammatory responses. The trial excludes patients on dialysis, those taking ARBs or sacubitril-valsartan, and patients with ACE inhibitor intolerance or angioedema history. The single-site study is conducted at UNS Hospital in Kartasura, Central Java.
Why it matters
Potential benefit: If successful, the trial could identify a ramipril dosing schedule that better preserves kidney function and lowers markers of inflammation and oxidative stress in CKD patients with reduced ejection fraction heart failure.
How similar studies have gone: ACE inhibitors like ramipril are proven to benefit CKD and HFrEF broadly, but direct randomized comparisons of once-daily versus twice-daily ramipril for renal biomarkers are limited, so this addresses a relatively novel practical question.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female or Male with age \>18 years old * Patients with a diagnosis of CKD stage 3-5 non-dialysis with low ejection fraction heart failure (ejection fraction \< 40%) Exclusion Criteria: * Receiving hemodialysis therapy * History of intolerance to ACE inhibitors * Refractory hyperkalemia * Pregnancy * History of angioedema to ACE inhibitors * Receiving sacubitril-valsartan therapy * Receiving ARB therapy * Hypotension with blood pressure \<90/60, or patients in shock.
Where it's running
-
UNS Hospital
Kartasura, Central Java, Indonesia Recruiting
Study contacts
- Study coordinator: Evi L Wulandari, MD., Internist
- Email: evililiek@staff.uns.ac.id
- Phone: (+62)821-3587-2749
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.